LEGAL action has been taken against pharmacies that allegedly smuggled unapproved Covid-19 rapid antigen testing kits into the country.
At least five types of illegal kits have been withdrawn from the Bahrain market by the National Health Regulatory Authority (NHRA).
The authority issued a warning yesterday to the public not to use them because they may produce inaccurate results.
The following products – Chil Covid Test kit, HopeGEN, Top Biotech Top Rapid Test Kit, Now Check Covid 19 Ag Test, and TIB Abtigen Test Kit – have been pulled from the shelves, according to the NHRA engineering consultant and acting head of the medical device regulation section, Nada Ghassan Alsayegh.
“These devices have not been approved by the NHRA. If anyone has purchased one of these products they are urged not to use them as they may not provide accurate results,” Ms Alsayegh told the GDN.
Ms Alsayegh
The Customs Directorate seized supplies of the illegal entries at the airport but some had slipped through the net. Inspectors tracked them down to a number of unnamed pharmacies.
“These kits were brought into the country illegally,” said Ms Alsayegh. “The Customs Directorate seized the illegal bulk. This involved several pharmacies and they have been referred for legal action.
“We also found them in the market during a routine inspection and the kits were withdrawn immediately from sale.
“We have also urged the entry ports to keep a strict watch so that such smuggled items, that can hamper public health, do not enter the country’s market.”
She added that the NHRA ensures extensive procedures and international standards are applied and followed when approving medical products.
“When we approve a product we go through two major phases. First, to make sure that the product is marketed worldwide with approval from internationally-recognised agencies and, secondly, that it has the required quality documents and data,” she explained.
“Then we ask the company to ship 100 samples which will further evaluated for accuracy and efficacy by the Public Health Directorate.”
Bahrain introduced rapid antigen Covid-19 tests in November 2020. The test, performed as a throat and nasal swab, gives results within 15 minutes with an accuracy rate of more than 93pc.
The kits, initially priced at BD4 each, were later made available in pharmacies across Bahrain for BD2.500.
The GDN reported in January of a severe shortage of rapid antigen test kits in the country as cases spiked as a result of the highly-contagious Omicron variant of Covid-19.
NHRA chief executive Dr Maryam Al Jalahma revealed that the authority was processing the ‘required shipments’ of approved test kits to be made available ‘in batches throughout February’.
She also stated that the authority had verified the available quantities of kits in the market and had communicated with agents and suppliers to provide the necessary quantities, as well as confirm dates of delivery of future shipments to Bahrain.
raji@gdn.com.bh
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